PRC · Drug-Coated Peripheral Transluminal Angioplasty Catheter
· Class 3
Overview
| Product Code | PRC |
|---|---|
| Device Name | Drug-Coated Peripheral Transluminal Angioplasty Catheter |
| Device Class | Class 3 |
| Review Panel |
Identification
Balloon dilatation of native and/or synthetic arteriovenous dialysis fistulae to establish or maintain patency
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P190008 | IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter | Medtronic Vascular, Inc. | Nov 21, 2019 | APPR |
| P170003 | LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010 | Lutonix | Aug 25, 2017 | APPR |
Top Applicants
- Lutonix — 1 clearance
- Medtronic Vascular, Inc. — 1 clearance
